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New study peers inside the heart and kidneys of people with type 1 diabetes

NCT ID NCT07270172

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study will use special PET scans to measure how much oxygen the heart and kidneys use in people with type 1 diabetes. Researchers want to see if a more intensive treatment plan (multifactorial intervention) lowers oxygen demand compared to standard care. Forty adults with type 1 diabetes and signs of kidney or heart disease will be followed for two years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population for the Steno1 Study is persons with Type 1 Diabetes at the Steno Diabetes Centre and at partner clinics in Region Midt, Denmark. The MICRON study will recruit from these participants.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Steno 1 inclusion criteria: * Male or female persons ≥40 years old with T1D (diagnosis before age 30 with insulin from onset or if diagnosis after 30 years of age insulin from onset and DKA or positive autoantibodies (in accordance with local guidelines), or confirmed, at the investigator's discretion by the available medical records) during \>10 years. * Presence of chronic kidney disease (UACR \>30 mg/g or eGFR \< 60 ml/min/1.73 m2) OR history of ischemic heart disease (previous myocardial infarction, stroke or angina) OR history of heart failure OR obesity grade 2 and 3 (BMI\>35 kg/m2) OR 5-year CVD risk \>10% according to Steno Type 1 Risk Engine. * Fertile females must use highly efficient chemical, hormonal and mechanical contraceptives during the whole study and at least 2 months after cessation of study drug. The following contraceptive methods are approved: IUD or hormonal contraception that inhibits ovulation, i.e. pills, implantations, transdermal patches, vaginal ring or depot injection. Alternatively, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least 12 months prior to screening. * Ability to communicate with the investigator and understand informed consent. * Given written informed consent. Steno 1 exclusion criteria: * Type 2 Diabetes, Maturity-onset diabetes of the young (MODY), secondary diabetes. * History of pancreatitis. * Body mass index \< 18.5 kg/m2 * Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods. * Known or suspected abuse of alcohol or recreational drugs. * Participant in another drug-intervention study. * Chronic Kidney Disease stage 5. Additional exclusion criteria in the MICRON study: * Active malignant disease * Use of study drugs (SGLT inhibitors, GLP-1 RA, or finererone) at inclusion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aarhus University Hospital

    RECRUITING

    Aarhus N, 8200, Denmark

  • Regionshospitalet Gødstrup

    RECRUITING

    Gødstrup, 7400, Denmark

  • Regionshospitalet Horsens

    RECRUITING

    Horsens, 8700, Denmark

  • Regionshospitalet Silkeborg

    RECRUITING

    Silkeborg, 8600, Denmark

  • Regionshospitalet Vibrg

    RECRUITING

    Viborg, 8800, Denmark

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